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CTRI Number  CTRI/2019/09/021292 [Registered on: 17/09/2019] Trial Registered Prospectively
Last Modified On: 09/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Measurements of major respiratory muscle by ultrasonography for separation from artificial ventilation machine in patients with hospital acquired pneumonia 
Scientific Title of Study   Diaphragmatic ultrasonography as a predictor index for weaning from mechanical ventilation in patients with nosocomial pneumonia: a prospective observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ECR/736/Inst/UK/2015/RR-18  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohammad Hashim 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Anaesthesiology and Critical Care Medicine AIIMS Rishikesh
Veerbhadra Road Rishikesh
Dehradun
UTTARANCHAL
249203
India 
Phone  9760171584  
Fax    
Email  buxhashim@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ankit Agarwal 
Designation  Additional professor 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Anaesthesiology and Critical Care Medicine AIIMS Rishikesh
Veerbhadra Road
Dehradun
UTTARANCHAL
249203
India 
Phone  8475000280  
Fax    
Email  drankit80@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mohammad Hashim 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Anaesthesiology and Critical Care Medicine AIIMS Rishikesh
Veerbhadra Road
Dehradun
UTTARANCHAL
249203
India 
Phone  9760171584  
Fax    
Email  buxhashim@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH 
 
Primary Sponsor  
Name  Dr Mohammad Hashim 
Address  Department of Anaesthesiology and Critical Care Medicine, AIIMS, Rishikesh 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Ajeet Singh Bhadoria  Department of Community and Family medicine, AIIMS, Rishikesh 
Dr Ankit Agarwal  Department of Anaesthesiology and Critical Care Medicine, AIIMS, Rishikesh 
Dr Rahul Dev  Department of Radio-diagnosis, AIIMS, Rishikesh 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mohammad Hashim  All India Institute of Medical Sciences, Rishikesh  Room no-218 SR Hostel AIIMS, Rishikesh, Veerbhadra Road
Dehradun
UTTARANCHAL 		 9760171584

buxhashim@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, All India Institute of Medical Sciences, Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J189||Pneumonia, unspecified organism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Diaphragmatic thickness fraction(DTF)   DTF ≥ 30% 
Comparator Agent  Diaphragmatic thickness fraction(DTF)  DTF less than 30% 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Patients aged ≥ 18 years with nosocomial pneumonia and on Mechanical Ventilation for more than 24 hours and satisfying conventional criteria for ready to wean from ventilator and undergoing for Spontaneous breathing trial 
 
ExclusionCriteria 
Details  1. Patients aged < 18 years, ventilated for less than 24 h
2. Patients with pre-existing diaphragm disease or any neuromuscular disorder.
3. Patients with increased intra-abdominal pressure
4. Patients with any breach in skin preventing DUS examinations in Sub-costal area
5. Phrenic nerve palsy
6. Pregnancy
7. Morbid obesity (BMI>40).
8. Patients deteriorated after 30 minutes of application of SBT.
9. Patient’s kin refusal to provide informed consent.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To identify the role of diaphragmatic ultrasound predictors: DTF for predicting the success of weaning from mechanical ventilation in icu patients with Nosocomial Pneumonia  28 days 
 
Secondary Outcome  
Outcome  TimePoints 
To identify the effect of diaphragmatic excursion (DE) and other measures (RSBI, PImax, Dynamic compliance, P 0.1) on weaning outcome in mechanically ventilated patients with nosocomial pneumonia in ICU.  28 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/09/2019 
Date of Study Completion (India) 31/12/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Nosocomial pneumonia is the second most common hospital-acquired infection and associated with increased ICU days, Ventilator days, morbidity and mortality in ICU patients. Mechanical ventilation is the crucial and integral element in ICU and saves many lives but difficult and delayed weaning is associated with diaphragmatic dysfunction because of contractile dysfunction and atrophy and associated with increased morbidity and mortality, so weaning should be considered earliest possible but on another side, premature withdrawal from mechanical ventilation is also associated with increased morbidity and mortality. 
More recently, lung and diaphragm ultrasound methods have been introduced, assessing pulmonary airway patterns and diaphragm function. In the present study, we aim to identify the role of diaphragmatic thickness fraction and excursion as measured by ultrasonography in weaning from mechanical ventilation in the patients with nosocomial pneumonia.
In this study sample will be divided in to two groups on the basis of Diaphragmatic Thickness Fraction(DTF), one with DTF of >30% and other with DTF of <30% then primary and secondary outcomes will be prospectively followed in these groups by the researcher who will be blinded to Diaphragmatic ultrasonography findings, for at least 72 hours or till the patient will be discharged from the ICU.
 
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